A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Summary
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Arms & interventions
- DrugINCB161734
INCB161734 will be administered at protocol defined dose.
- DrugCetuximab
Cetuximab will be administered at protocol defined dose.
- DrugRetifanlimab
Retifanlimab will be administered at protocol defined dose.
- DrugGEMNabP
GEMNabP will be administered at protocol defined dose.
- DrugmFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
- DrugFOLFOX
FOLFOX will be administered at protocol defined dose.
- DrugFOLFIRI
FOLFIRI will be administered at protocol defined dose.
- DrugINCA33890
INCA33890 will be administered at protocol defined dose.
Outcome measures
Primary
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.
Time frame: Up to 2 years and 90 days
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Time frame: Up to 2 years and 90 days
Secondary
INCB161734 pharmacokinetic (PK) in Plasma
Time frame: Up to approximately 90 days
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease Control Response (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Eligibility criteria
Study locations (16)
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Stanford University
Palo Alto, California, 94305
UCLA Healthcare Hematology-Oncology
Santa Monica, California, 90404
Sarah Cannon Research Institue At Healthone
Denver, Colorado, 80218
Mayo Clinic Florida
Jacksonville, Florida, 32224
Florida Cancer Specialists
Sarasota, Florida, 34232
Florida Cancer Specialists
Sarasota, Florida, 34232
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21287
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic
Rochester, Minnesota, 55905
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Weill Cornell Medicine
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
Scri Oncology Partners
Nashville, Tennessee, 37203
Md Anderson Cancer Center
Houston, Texas, 77030